Kornimate/medical-research-clean huggingface dataset:
metformin and muscle in insulin-resistant older veterans

Conditions: Prediabetes

Summary: sarcopenia is the loss of muscle mass, strength and function with aging and is associated with increased disability, falls and fractures. older adults with diabetes and prediabetes are insulin resistant and have a higher risk of developing sarcopenia. this study examines the use of metformin, an antidiabetic drug, for preventing the development of sarcopenia in older adults with prediabetes.

the proposed study utilizes clinical and translational research approaches to study sarcopenia. sarcopenia is common in older adults and is associated with decreased strength, increased disability, falls and fractures. there are currently few interventions to prevent or treat sarcopenia and a poor understanding of the mechanisms for sarcopenia. given the growing number of veterans over the age of 65, studies to prevent sarcopenia and resulting disability are important for the health, independence and well-being of this population. the investigators' preliminary studies have shown that older adults with diabetes have an accelerated loss in muscle mass and gait speed, except when treated with metformin. older adults with prediabetes also have a greater decline in muscle mass and higher incidence of disability. therefore, this study further investigates these findings by addressing the following aims: (1) to determine whether metformin can prevent the loss in muscle mass and physical performance and (2) to examine changes in muscle histologic characteristics associated with metformin treatment in older adults with prediabetes.

Eligibility criteria:
inclusion criteria: * the investigators will enroll 120 sedentary, weight-stable, ambulatory veterans aged 65 years and older with prediabetes identified with fasting glucose values 100 mg/dl or greater but under 126 mg/dl with no use of diabetes medications. * participants must demonstrate that they are able to ambulate 400 meters without assistance. exclusion criteria: * chronic medical conditions affecting muscle mass or function like active non-skin cancer and hypogonadism * medications affecting muscle mass or function like glucocorticoids and androgen/antiandrogens * contraindications to metformin such as renal dysfunction defined as creatinine \>= 1.5 mg/dl for men or \>=1.4 mg/dl for women or estimated glomerular filtration rate (egfr)\ 48 u/l, aspart aminotransferase (ast)\>41 u/l or alkaline phosphatase (alkphos)\>141 u/l; b12 deficiency defined as b12 level \<180 pg/dl; congestive heart failure; known hypersensitivity to metformin; excessive alcohol intake (average of 2 or more alcoholic beverages/day over a month) for the muscle biopsy substudy, additional exclusion criteria include: * conditions that include bleeding risk such as the use of warfarin, clopidogrel/ticlopidine, aggrenox, dabigatran or anagrelide; laboratory results showing platelets\ 1.2 or activated partial thromboplastin time (aptt)\>36 seconds * allergy to lidocaine

Keywords: metformin muscle insulin resistance sarcopenia older adults impaired fasting glucose
study testing the biologic activity and safety of an immunotherapeutic in patients with newly diagnosed stage iv kidney cancer

Conditions: Renal Cell Carcinoma

Summary: the purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of multiple administrations of dendritic cell immunotherapeutic to patients with newly diagnosed with metastatic kidney cancer

in this study, a new immunotherapeutic production process will be used that shows evidence of potentially much higher biologic activity in pre-clinical studies than the production process used in a previous study (clinical protocol mb-002-003). while both processes are based on individual subject autologous tumor rna and autologous monocyte derived dcs, the maturation of dcs in this newly modified process involves an altered regimen of culture with cytokines. in addition, hucd40l mrna is added to the autologous expanded tumor total mrna for electroporation. these changes promise a much improved migration, and activity profile of the dc-immunotherapeutic product in rcc subjects.

Eligibility criteria:
inclusion criteria: * have a new diagnosis of metastatic renal cell carcinoma; * measurable disease * must be at least 18 years or older; * have a scheduled unilateral nephrectomy or excisional biopsy/metastasectomy * ecog of 0 or 1; * free of brain metastases by ct or mri; * normal renal function in contralateral kidney; * male or non-pregnant/non-lactating female on appropriate birth control methods while on study; * clinically acceptable screening results. * no immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry; * no active autoimmune disease

Keywords: kidney cancer renal cancer
upper limb function in mental health disorders

Conditions: Mental Health; Multiple Sclerosis

Summary: background: individuals with mental disorders (md) often experience motor issues, yet upper limb functionality remains understudied. objective: to compare upper limb function in individuals with and without md, focusing on motor capacity, dexterity, and performance. design: cross-sectional, qualitative, multicenter study. methods: assessed strength, motor skills, sensitivity, and daily function. used t-test, mann-whitney u, spearman correlation, and chi-square.

background: research suggests individuals with mental disorders (md) often face motor difficulties, such as issues with gait and posture. however, there is limited research on upper limb functionality in the mental health context. objective: to compare upper limb functionality between individuals with and without md, focusing on differences in motor capacity, manual dexterity, and functional performance. study design: cross-sectional, qualitative, multicenter study. methods: strength, fine and gross motor skills, sensitivity, tactile discrimination, and were assessed, along with functional limitations in daily activities. statistical methods used included independent samples t-test, mann-whitney u test, spearman correlation, and chi-square test.

Eligibility criteria:
inclusion criteria: mental disorder group * participants with a mental disorder (md) had to meet the following criteria: * a formal diagnosis of a mental disorder according to the dsm-v. * aged between 18 and 65 years. * treatment stability, defined as being under stable pharmacological and psychiatric treatment for at least three months. * clinical stability, meaning no acute psychiatric episodes in the last three months that could interfere with participation in the study. * ability to follow instructions and communicate effectively, confirmed by scoring at least 23 points on the mini-mental state examination (mmse). control group (healthy participants) * healthy individuals were required to meet the following inclusion criteria: * aged between 18 and 65 years. * ability to follow instructions and communicate effectively, also defined by a minimum mmse score of 23. exclusion criteria: * presence of neurological conditions, such as multiple sclerosis, stroke, or similar disorders. * history of upper limb rehabilitation within the past six months. * any acute or chronic condition affecting the upper limb that could interfere with the results, including but not limited to arthritis, osteoarthritis, or carpal tunnel syndrome.

Keywords: mental disorders upper extremity hand strength motor skills hand
a trial of ligation plus nadolol versus nadolol alone in the prophylaxis of first variceal bleeding in cirrhosis

Conditions: Variceal Bleeding; Cirrhosis

Summary: the value of banding ligation plus beta blocker in the prophylaxis of first episodes of variceal bleeding has not yet been evaluated. this study was conducted to compare the efficacy and safety of banding ligation plus nadolol versus nadolol in the prophylaxis of first bleeding in cirrhotic patients with high-risk esophageal varices.

currently, endoscopic variceal ligation (evl) has replaced eis as the endoscopic treatment of choice for management of bleeding esophageal varices. the advantages of evl include requiring fewer treatment sessions to achieve variceal obliteration, lower rebleeding rates and fewer complications (5-9). controlled studies that compared evl with beta-blocker in the prevention of first variceal bleeding suggested that evl was at least equal to beta-blockers in the prophylaxis of first variceal bleeding. however, portal pressure may be elevated after repeated evl. hence the combination of nadolol and evl is a reasonable approach to prevent the first episode of variceal bleeding.

Eligibility criteria:
inclusion criteria: 1. the cause of portal hypertension was cirrhosis 2. the degree of esophageal varices was f2 (moderate varices) or more, associated with any of red color signs (red wale markings, cherry red spots or hematocystic spots) 3. no history of hemorrhage from esophageal varices 4. no current treatment with beta-blockers 5. cirrhosis was based on results of liver biopsy, or clinical and biochemical examinations and image studies exclusion criteria: 1. age greater than 75 years old or younger than 20 years old 2. association with malignancy, uremia or other serious medical illness which may reduce the life expectancy 3. presence of refractory ascites, hepatic encephalopathy or marked jaundice (serum bilirubin \> 10 mg/dl) 4. history of shunt operation, transjugular intrahepatic portosystemic stent shunt or endoscopic therapy (eis or evl) 5. had contraindications to beta-blockers, such as asthma, heart failure, complete atrioventricular block, hypotension ( systolic blood pressure \< 90 mmhg), pulse rate \< 60/ min 6. unable to cooperate

Keywords: prophylaxis ligation beta blockers first bleeding rate
stress evaluation and management using high fidelity simulation in medical education

Conditions: Stress; Pupillometry; High Fidelity Simulation Training; Resident Education; Heart Rate Variability, Biomarker of Stress; Simulation Training

Summary: the goal of this interventional study is to collect clinical and neurophysiological information to determine whether high-fidelity simulation can serve as a stress-inducing stimulus in a population of healthy residents (emergency medicine, anesthesia and intensive care medicine, paediatrics), both male and female, aged between 25 and 40 years. the main questions it aims to answer are: 1. define in which phase of the simulation the highest level of stress is observed. 2. determine the level of stress reached after performing a second high-fidelity simulation after a period of time. 3. identify whether specific brain areas are activated during high-fidelity simulation. participants will form teams, consisting of three medical trainees from the same specialty training program, that will undergo two high-fidelity simulations based on a clinical scenario relevant to their residency. * during the simulation, automatic pupillometry will be performed on all team members at the four time points. * additionally, a two-lead ecg will be recorded for all team members at baseline and end of the debriefing * one team member will undergo eeg monitoring throughout the entire simulation. the eeg recordings will be sampled at baseline, during the simulation and end of the debriefing.


Eligibility criteria:
inclusion criteria: * medical trainees from the specialties of emergency medicine, anesthesia and intensive care, clinical toxicology, pediatrics, and neonatology. * normal hearing and vision, or corrected to normal. exclusion criteria: * known history of psychiatric disorders, cognitive impairment, or cardiac arrhythmias. * current treatment with psychoactive, cardio-stimulant, or cardio-inhibitory medications. * significant stressful life events in the past six months (e.g., family bereavement). * previous systematic experience in meditation.
outreach for patients that are newly eligible for colorectal cancer screening

Conditions: Colorectal Cancer

Summary: the purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventative screenings for those patients who, based on national quality standards, have become newly eligible for screening measures. we hypothesize that educational outreach may increase completion rates.


Eligibility criteria:
inclusion criteria: * patient of northwestern medical faculty foundation general internal medicine * patient has a scheduled appointment with a gim physician in the next several weeks * patient will be 50 years old at the time of this appointment * patient is male or female exclusion criteria: * this is the first time the patient is seen in the nmff gim clinic * there is a prior completion of crc screening noted in ehr. * there is a prior order placed for crc screening in ehr. * patient has a history of crc * patient has a diagnosis of ulcerative colitis, inflammatory bowel disease, crohn's disease, or documented colectomy.

Keywords: education preventive service screening colorectal cancer screening prevention & control
differential plasma microrna profiles in ed and normal erectile function in older males

Conditions: Erectile Dysfunction

Summary: erectile dysfunction (ed) is strongly associated with aging. with the rapidly expanding aging population and the increase in life expectancy, an increase in the prevalence of ed is expected in the years to come. currently, the mechanism of ed is not fully understood. micrornas (mirna) are endogenous small rna molecules that control gene expression post-transcriptionally. it has been included in many in vitro physiology and pathophysiology processes, which also involved in the process of ed. this research was designed to investigate the differential plasma mirna profiles in ed and normal erectile function in older males. the results might tell us which mirna and how did it involved in the process of ed in aging.


Eligibility criteria:
inclusion criteria: * older males with erectile dysfunction exclusion criteria: * have some other general diseases, e.g. hypertension, vascular diseases, depression, chronic kidney disease, diabetes.
effects of lifestyle intervention on childhood outcomes in lga infants

Conditions: Childhood Overweight

Summary: large-for-gestational-age (lga) infants have a higher risk of metabolic disease later in life, and their postnatal growth in early childhood may be associated with long-term adverse outcomes. the purpose of this study is to explore whether comprehensive lifestyle intervention in the first year after birth in lga infants will reduce the rate of overweight/obesity at childhood and improve neurodevelopmental outcomes and its possible mechanism.

term lga infants will be randomly divided into two groups shortly after birth: intervention group and control group. infants in intervention group will attend the follow-up clinic and motor development assessment and guidance will be provided every three months in the first year. other lifestyle interventions include feeding guidance and healthcare education. infants in control group will routinely attend the follow-up clinic every six months. primary outcome is the rate of overweight/obesity at two years old and seven years old. neurodevelopmental assessment, carotid intima-media thickness (cimt) and blood pressure at childhood will also be evaluated. the association of the outcome of lga infants at two years old and the biomarkers in cord blood will be investigated, which includes serum leptin, insulin, insulin-like growth factors -1 (igf-1), blood lipid series and adiponectin.

Eligibility criteria:
inclusion criteria: * term * large-for-gestational-age infants exclusion criteria: * major genetic disorder * congenital anomalies * severe digestive disease

Keywords: large for gestational age
busulfan concentration in saliva and plasma, and its relationship with salivary changes and mucositis in the digestive tract of patients submitted to hematopoietic stem cell transplantation

Conditions: Bone Marrow Disease

Summary: busulfan (bu) has been widely used for the treatment of neoplastic and non-neoplastic hematological disturbances, with satisfactory results in terms of successful hematopoietic stem cell transplantation (hsct). individual monitoring of the bu dosage, which is done by means of various blood sample collections, is necessary for the purpose of attaining ideal therapeutic levels and minimizing systemic toxicity. this procedure sometimes becomes costly to and uncomfortable for the patient. saliva has been analyzed as a possible alternative fluid for this monitoring.

the first objective of this project is to verify the feasibility of using the analysis of salivary concentration of bu during individual adjustments of this drug in the period that precedes hsct. another question related to this project is with reference to the effects that the bu concentration in saliva has on the mucosa of the digestive tract, particularly with regard to mucositis and salivary changes. thus, the second objective of this project is to verify whether there is any association between salivary changes, cytological changes in the oral mucosa, degrees of mucositis and concentration of bu in saliva. an analysis will be performed of the bu concentration in saliva and in blood, as well as the salivary dosage of total proteins, albumin, amylase, antioxidant enzymes (superoxide dismutase, catalase, and glutathione reductase) and pro-inflammatory cytokines il-1β, il-6 and tnf-α. in addition, morphological analysis will be made, and rate of apoptosis of cells of the oral mucosa will be analyzed. if the efficacy of saliva for the individual adjustment of the dose of bu is confirmed, this method could facilitate the dissemination of pharmacokinetic monitoring of this drug in chemotherapy and hsct centers. in addition, it is expected that the results of the present project will allow establishment of the toxicity indicators of bu detected by analysis of saliva and the cells of the oral mucosa, thereby allowing the early adoption of preventive actions for reducing the frequency and severity of mucositis, a fact that may have a positive impact on the success of hsct.

Eligibility criteria:
inclusion criteria: * submitted a tcth exclusion criteria: * no signed informed consent
empower study, a personalized home care intervention for older heart failure patients

Conditions: Heart Failure

Summary: the purpose of this study is to see how investigators may best improve treatment adherence and disease management for heart failure after hospital discharge. this is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of future hospitalizations. in this study, a trained nurse interventionist will work with the participants to develop a personalized adherence enhancement strategy for heart failure diagnosis. the personalized adherence enhancement strategy is called empower.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate/severe heart failure at hospital admission, defined by icd codes (icd-9 428 or icd-10 150), new york heart association class iii/iv, and left ventricular ejection fraction less than or equal to 40% (i.e., echocardiography) * discharge from heart failure-led hospitalization to home health care in approximately the previous week * intact or mildly impaired cognitive function (montreal cognitive assessment eligibility scores greater than or equal to 18) * primary residence in four counties within 30 minutes distance to the university of rochester exclusion criteria: * end-of-life prognosis in the following 6 months that make it difficult to examine the changes in heart failure outcomes * currently receiving hospice care * conditions that impact the receipt of the intervention such as active suicidal ideation that is identified at baseline using the geriatric depression scale and the geriatric suicide ideation scale * being non-english speaking * having serious visual and or hearing impairment
use of a biological lens of amniotic membrane (lv-visio-amtrix) in the treatment of trophic ulcers

Conditions: Corneal Ulcer; Persistent Corneal Epithelial Defect

Summary: the purpose of this open, multicenter pilot trial is to assess the impact of the use of an amniotic membrane on the healing of a persistent epithelial lesion or of a corneal ulcer.


Eligibility criteria:
inclusion criteria: * male or female between 18 and 80 years old * stage 2 (persistent epithelial lesion : lep) or stage 3 (corneal ulcer) trophic ulcer affecting only one eye. patient whose contralateral eye is affected by stage 1 neurotrophic keratitis may also be included * two or more weeks old lep or corneal ulcer refractory to one or more conventional nonsurgical therapies * absence of objective evidence of improvement of the epithelial ulceration or corneal ulcer within 2 weeks prior to study inclusion * failure of amniotic membrane treatment of the trophic ulcer: failure by absence of healing a few day after overlay treatment or 15 days after inlay grafting * patient able to understand french language * informed and consenting patient * patient affiliated to a social security system or beneficiary of such a system exclusion criteria: * pregnant or breastfeeding patient or without contraception for non-menopausal women * active infectious ulcer * preperforating ulcer or ulcer that has reached the posterior 1/3 of the storm * allergy to oxybuprocaine or tetracaine eye drops, to ester type local anesthetics and to fluorescein * current contact lens wear, including scleral lenses * nsaid eye drops and any drops containing preservatives * antibiotic, anti-viral, anti-parasitic eye drops * patients with identified causes of the ulcer for which medical treatment without preservatives or other healing treatment is beneficial * ocular surgery for other pathology than the trophic ulcer in the 3 months preceding the inclusion in the study * ophthalmologic pathology requiring daily eye drops * monophtalmic patients * persons deprived of liberty by a judicial or administrative decision * adults who are subject to a legal protection measure or who are unable to express their consent